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XVIVO presents Report on Opera...

XVIVO presents Report on Operations 2021

Year ends on strong quarter

Fourth quarter 2021 (October 1 – December 31)
• Net sales amounted to SEK 85.9 million (60.3), corresponding to an increase of 42 percent in SEK and 42 percent also in local currencies.
• Net sales of non-durable goods amounted to SEK 74.0 million (54.9), corresponding to an increase of 35 percent in SEK and 34 percent in local currencies.
• Organic growth amounted to 32 percent in local currencies.
• Machine perfusion accounted for 55 percent (56) of net sales.
• Operating profit before depreciation and amortization (EBITDA) amounted to SEK- 0.1 million (-6.5), corresponding to an EBITDA margin of 0 percent (-11). Adjusted EBITDA amounted to SEK 9.6 million (6.8), corresponding to an adjusted EBITDA margin of 11 percent (11).
• Operating profit (EBIT) amounted to SEK -8.3 million (-14.3). Adjusted EBIT amounted to SEK 1.4 million (-1.0).
• Net profit amounted to SEK 12.2 million (-19.6). Earnings per share amounted to SEK 0.42 (-0.68).
• Cash flow from operating activities amounted to SEK -0.6 million (-22.0). Total cash flow amounted to SEK 111.2 million (-245.9), primarily a net of proceeds from directed new share issue and the purchase price paid for acquisition and investments in R&D projects.
• Cash and cash equivalents at the end of the quarter amounted to SEK 398.7 million (354.2).

Significant events during the quarter
• XVIVO acquired 100 percent of the shares in the US organ recovery company Star Teams. The acquisition took place at a purchase price of up to USD 26.1 million with an initial purchase price of USD 12.3 million and an additional potential earn-out of up to USD 13.8 million.
• The acquisition of STAR Teams was financed by a new share issue whereby the company raised SEK 250 million before transaction costs. In addition to strong support from existing shareholders, several new Swedish and international institutional investors participated.
• With XVIVO's heart preservation technology a donor heart could be kept alive for 7 hours and 18 minutes before being successfully transplanted. This means a record when using XVIVO's technology in a clinical trial and was achieved by an Australian clinic.
• XVIVO is accelerating the business operations in Brazil, the world's third largest organ transplantation market, by signing a partnership contract with Contatti Medical, market leader on Brazil’s organ transplantation market.
• The North American organization has been strengthened further by the appointment of Fredrik Dalborg as Managing Director North America, and by the appointment of Jaya Tiwari as VP of Clinical and Regulatory Affairs for the US. Also, a new office was opened in Philadelphia.

The period (January 1 – December 31)
• Net sales amounted to SEK 258.4 million (179.9), corresponding to an increase of 44 percent in SEK and 50 percent in local currencies.
• Net sales of non-durable goods amounted to SEK 234.0 million (169.4), corresponding to an increase of 38 percent in SEK and 45 percent in local currencies.
• Organic growth amounted to 27 percent in local currencies.
• Machine perfusion accounted for 53 percent (43) of net sales.
• Operating profit before depreciation and amortization (EBITDA) amounted to SEK 13.8 million (-15.6), corresponding to an EBITDA margin of 5 percent (-9). Adjusted EBITDA amounted to SEK 29.5 million (20.2), corresponding to an adjusted EBITDA margin of 11 percent (11).
• Operating profit (EBIT) amounted to SEK -18.5 million (-45.7). Adjusted EBIT amounted to SEK -2.7 million (-9.9).
• Net profit amounted to SEK 8.2 million (-43.7). Earnings per share amounted to SEK 0.28 (-1.61).
• Cash flow from operating activities amounted to SEK -12.1 million (-12.3). Total cash flow amounted to SEK 34.8 million (204.0), primarily a net of the proceeds from directed new share issue and the purchase price paid for acquisition and investments R&D projects.
• Cash and cash equivalents at the end of the period amounted to SEK 398.7 million (354.2).

Significant events in the period
• Publication in reputable scientific journal The New England Journal of Medicine shows significant benefits of oxygenated cold machine perfusion prior to liver transplantation.
• Guidelines from NICE supporting EVLP as the standard lung preservation procedure were issued in the UK.
• Strategic focus areas were presented at XVIVO's first Capital Markets Day. These will support the company's goal to become the leading player in the transplant industry during the strategy period 2022-2026.
• A pilot project in advanced data analysis from liver perfusion was initiated with UMC Groningen as a partner.

Events after the reporting period
• On January 7, 2022, XVIVO’s innovative technology for heart preservation was used in the world’s first ever successful pig to human heart xenotransplantation. A team at the University of Maryland School of Medicine, USA, performed the procedure.
• On January 21, 2022, XVIVO obtained 510(k) approval by the FDA for marketing and sales of the product Kidney Assist Transport on the US market. The product is a transport device for kidney and the features of the technology were highlighted in the scientific journal The Lancet in November 2020.
• The Board proposes no dividend to be paid for the 2021 financial year and retained earnings to be carried forward.

CEO Comment
“XVIVO’s strong conclusion to 2021 generates positive prospects for the coming year. Fourth-quarter sales were solid and new sales records were set in all business areas. It was particularly pleasing that revenue from machine perfusion increased as activity intensified or restarted in several EVLP programs in clinics across the US and Europe. XVIVO acquired the groundbreaking organ recovery company STAR Teams in the quarter, a strategically significant acquisition on the key US market. The integration came off to an enthusiastic start and STAR Teams returned strong growth in the fourth quarter.” – Dag Andersson, CEO XVIVO.

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